Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

Can incapacitated subjects provide consent as soon as they regain capacity?

1. Yes

2. No

3. Only with additional approval

4. Only if they agree to do so

The correct answer is: Yes

The assertion is that incapacitated subjects can provide consent as soon as they regain capacity. This is grounded in the understanding that consent is inherently tied to the mental and emotional state of an individual. When a person is incapacitated, they are unable to make informed decisions, and thus cannot provide valid consent. However, once the individual regains their capacity—meaning they have returned to a state of mental competency where they can understand the information presented to them, consider the implications of their decisions, and appreciate the consequences—they are again able to give valid consent. This understanding acknowledges the essential principle that consent must be informed and voluntarily given. When a subject regains their capacity, the law and ethical standards recognize their right to make decisions for themselves, including the ability to consent to participation in research or other activities. Therefore, the answer reflects a key principle in ethics and law regarding consent: the capacity to consent is contingent on the individual’s mental state at the time of consent, not on their previous state of incapacity.